Events

Recall of Sechrist Hyperbaric Chamber Gurney.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sechrist Industries Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60466
  • Event Risk Class
    Class 2
  • Event Number
    Z-0816-2012
  • Event Initiated Date
    2009-09-15
  • Event Date Posted
    2012-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105498
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stretcher, wheeled - Product Code FPO
  • Reason
    Stryker medical has received complaints from customers that indicate a bushing in the braking system may fracture, which could result in the brake/steer pedal seizing. if the pedal seizes, the braking system may become inoperable or steering around corners may come more difficult. while no injuries have been associated with these reported events nor has there been reported failure events resulting.
  • Action
    Sechrist Industries sent a Urgent Medical Device Correction letter dated September 9, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Locate the gurneys with the serial numbers listed in this advisory. 2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location. 3.Verify the braking system is working properly. If the brake system is inoperable, or if the brake and /or steer require a greater than normal force to engage, remove the stretcher from service and contact Stryker Medical at 800-Stryker, option 3. Reference RA-2009-135. Do not put the stretcher back into service until is repaired by the Stryker field representative. 4. Contact Stryker Medical to schedule a service call for replacement of the bushing and mating parts of the stretcher. 5.Complete retrofit of the Gurney. 6.Verify correct function of the brake assembly following retrofit. 7.Complete and send the Correction Verification Form contained with this notice to Sechrist. For further questions please call (714) 579-8400. .

Device

Sechrist Hyperbaric Chamber Gurney.
  • Model / Serial
    Models 722, 734, 736, 737, 738, 1007, 1027, and 1079 Stryker Medical Street
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Peru, Venezuela, Brazil, Egypt, Mexico, Austrailia, Denmark and Taiwan
  • Product Description
    Sechrist Hyperbaric Chamber Gurney. || The Sechrist Hyperbaric Chamber Gurney is an accessory device to the Sechrist Monoplace Hyperbaric Chambers. It is intended solely for the loading and unloading of patients into Sechrist Monoplace Hyperbaric Chambers. It is not intended for general hospital patient transport and is sold only to be used in conjunction with Sechrist Monoplace Hyperbaric Chambers.
  • Manufacturer
    Sechrist Industries Inc

Manufacturer

Sechrist Industries Inc
  • Manufacturer Address
    Sechrist Industries Inc, 4225 E La Palma Ave, Anaheim CA 92807-1815
  • Manufacturer Parent Company (2017)
    Sechrist Industries Inc.
  • Source
    USFDA